Helical balloon catheter

ABSTRACT

Methods and devices described for improved catheters including those having a deflectable section to allow for expansion while maintaining flow through a vessel.

RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/043,608 filed Oct. 1, 2013, which is a non-provisional of U.S.Provisional Application No. 61/734,860 filed on Dec. 7, 2012; U.S.Provisional Application No. 61/724,875 filed on Nov. 9, 2012; and U.S.Provisional Application No. 61/708,524 filed on Oct. 1, 2012. Theentirety of each of which is incorporated by reference herein.

BACKGROUND OF THE INVENTION

There remains a need for a balloon catheter that can be deployed toprovide a radial outward force against a body lumen wall without causingocclusion of the body lumen. Such a catheter can be constructed toprovide varying expansive characteristics such as a low or high radialoutward force, a low or high ratio of expansion, as well as provide theability to navigate through tortuous anatomy.

SUMMARY

Methods and devices described herein provide for improved cathetersincluding those having a deflectable section to allow for expansionwhile maintaining flow through a vessel. While the following disclosurediscusses devices and methods for use in body vessels, such methods anddevices can be applied to various body portions.

The present disclosure includes catheters having a proximal portion,distal portion, and a deflectable section located therebetween, thedeflectable section having a deflectable cross section; where thedeflectable section cross section comprises an elastic material on afirst side and a flexible support material on a second side, aninflation lumen bounded by both the elastic material and the flexiblesupport material, and where the deflectable section cross sectionrotates along a length of the deflectable section such that the elasticmaterial, inflation lumen and flexible support material extend helicallyalong the length of the deflectable section; a pull wire extendingthrough the flexible support material at least along the length of thedeflectable section and at least to the proximal portion of thecatheter, such that proximal tension applied to the pull wire causes thedeflectable section to deflect into a helical profile; and wherein whena pressure within the inflation lumen increases, the elastic materialexpands away from the inflation lumen.

In one variation, the helical profile the flexible support material islocated along an internal diameter of the helical profile and theelastic material is located on an external diameter of the helicalprofile such that upon increasing the pressure within the inflationlumen the elastic material expands radially outward from the helicalprofile.

In another variation, the pull wire extends through a pullwire lumen andwhere the pull wire lumen and inflation lumen are located 180 degreesopposite in the deflectable section cross section.

Variations of the devices can include a guidewire lumen extendingthrough the proximal portion and flexible support material of thedeflectable section. The devices can also optionally include one or moreguidewire lumens that extend through a center of the proximal portion,distal portion, and the deflectable section.

In one example, the guidewire lumen extends through the distal portion.

The devices can also optionally include an inflation lumen that extendsthrough the proximal portion.

In variations of the device, a flexible support material durometer isless than a proximal portion durometer.

The devices can include helical deflectable sections having at least oneturn or

a plurality of turns where the helical profile has a pitch and adiameter.

The devices can include variations where at least two turns of theplurality of turns is contiguous along a length of the helical profile.In additional variations, at least two turns of the plurality of turnsare spaced and do not touch along a length of the helical profile.

In some variations, where the pitch of the helical profile is consistentfor the plurality of turns. Alternatively, the pitch of the helicalprofile can vary for the plurality of turns. Furthermore, the diameterof the helical profile can be consistent along a length of the helicalprofile or can vary.

The present disclosure also includes methods for performing a medicalprocedure within a body lumen. In one example such a method includesadvancing a catheter into the body lumen, the catheter having a proximalportion, distal portion, and a deflectable section located therebetween,where a deflectable section cross section comprises an elastic materialon a first side and a flexible support material on a second side, aninflation lumen bounded by both the elastic material and the flexiblesupport material, and where the deflectable section cross sectionrotates along a length of the deflectable section such that the elasticmaterial, inflation lumen and flexible support material extend helicallyalong the length of the deflectable section; converting the deflectablesection from a near linear shape to a helical shape by applying tensionto a pull wire extending through the flexible support material at leastalong the length of the deflectable section and at least to the proximalportion of the catheter, such that tension in the pull wire causes thedeflectable section to deflect into the helical shape; and expanding theelastic material by increasing a pressure within the inflation.

In another example, the method includes expanding the elastic materialby expanding the elastic material against a wall of the body lumen toapply an outward radial force on the wall of the body lumen, whileallowing a passage through the helical shape such that the body lumen isnot occluded by the catheter.

In another example, the method can include positioning the deflectablesection of the catheter within a second medical device, and whereexpanding the elastic material causes the second medical device toexpand against a wall of the body lumen while allowing a passage throughthe helical shape such that the body lumen is not occluded by thecatheter.

The present disclosure also includes another variation of a catheterhaving a proximal portion, distal portion, and a deflectable sectionlocated therebetween; where a deflectable section cross sectioncomprises an elastic material on a first side and a flexible supportmaterial on a second side, an inflation lumen bounded by both theelastic material and the flexible support material, and where thedeflectable section cross section has two materials with differentYoung's modulus along a length of the deflectable section such that theelastic material, inflation lumen and flexible support materials changelengths at different rates during the inflation of the elastic portionof the tubing with the elastic balloon material elongating relative tothe flexible support material of the catheter lumen which deflects thedeflectable section into a coiled or helical shape that is; cylindricalcone or hooked shaped;

Such a Young's modulus can optionally be determined by

$F = {- \frac{{EA}_{0}\Delta \; L}{L_{0}}}$

Variations of the access device and procedures described herein includecombinations of features of the various embodiments or combination ofthe embodiments themselves wherever possible.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1A illustrates a catheter having a deformable section that canassume a helical configuration.

FIG. 1B illustrates a proximal force applied to a pull wire to cause thedeflectable section to assume a helix or helical profile.

FIG. 1C shows a perspective view of a catheter that is in the helicalconfiguration.

FIGS. 1D to 1H illustrate an expandable configuration of the catheter'sdeflectable section. FIGS. 1E to 1H show that a lumen of the deflectablesection can non-symmetrically expand. FIGS. 1E to 1H show that elasticmaterial of the deflectable section can expand non-symmetrically.

FIGS. 2A to 2K show how a cross section of the deflectable sectionrotates along a length of the deflectable section.

FIGS. 3A to 3C illustrate additional variations of the helical shapesfor use with variations of catheters described herein.

FIG. 4A to 4C show a single turn catheter.

FIGS. 5A to 5C show an example of a catheter with a deformable sectionbeing used to deploy a medical device within a body lumen.

FIGS. 6A and 6B show a variation of the device where a guidewire lumenexits at one side of the deflectable section and reenters the device ata distal section.

FIGS.7A and 7B show another variation of a device having an actuatorthat allows for expansion of the deflectable section as it forms thehelical turns.

FIGS. 8A to 8D illustrate variations of devices having fluid deliverylumens .

FIGS. 9A and 9B show ports on the exterior of the deflectable section.

FIG. 10 shows a variation of a device expanded in an artery anddelivering a fluid.

FIGS. 11A and 11B show additional variations of the device.

FIGS. 12A to 12D show a variation of a device with an addition wire orsuture used to assist the deflectable section when forming a coil orhelix.

DETAILED DESCRIPTION OF THE INVENTION

The following illustrations demonstrate various embodiments and examplesof the devices and methods according to the present disclosure.Combinations of aspects of the various devices and methods orcombinations of the devices and methods themselves are considered to bewithin the scope of this disclosure.

FIG. 1A illustrates a variation of a catheter 100 according to thepresent disclosure. FIG. 1A depicts the catheter 100 in a generallylinear configuration; however, the catheter 100 can optionally beconfigured to be flexible to navigate through tortuous anatomy such asthe vasculature and/or other organs throughout the body. FIG. 1A showsthe catheter including a distal portion 102 having an optional lumenterminating at a distal end 114. The catheter 100 also includes aproximal portion 106 that is used by an operator to manipulate thecatheter 100. Variations of the catheter 100 can include any number ofhubs or handles located towards the proximal end of the proximal portion106. The catheter 100 includes a deflectable section 104 located betweenthe proximal portion 106 and distal portion 102. As discussed below, thedeflectable section 104 can be actuated by a user via a pull wire 108 orother similar means. Variations of the device 100 can include a catheter100 without a distal portion 102 or with a deflectable section 104 thatextends along a significant length of the catheter 100. The deflectablesection 104, as described in detail below, includes a cross section thatrotates along a length of the deflectable section 104 and as depicted by118. The rotated cross section comprises at least two differentmaterials that extend helically along a length of the deflectablesection 104.

FIG. 1B illustrates a proximal force 116 applied to the pull wire 108 tocause the deflectable section 104 to assume a helix or helical profile110. The rotated cross section of the deflectable section 104 results inthe helical deflection of the deflectable section 104 upon applicationof a tensile force on the pull wire 108 that extends through at least aportion of the deflectable section. The variation illustrated in FIG. 1Bdemonstrates a helical shape 100 having 4 turns 112. However, thedevices and methods described herein can include any number of turns 112as well as alternate helical configurations as shown below.

FIG. 1C shows a perspective view of a catheter 100 having a deflectablesection 104 in a helical profile, as shown the helical profile 110includes a passage 120 that prevents the catheter 100 from occluding thebody lumen when in a helical configuration.

FIG. 1D illustrates another variation of a catheter 100 under thepresent disclosure. In this variation, the deflectable section 104 ofthe catheter 100 can expand. FIG. 1E illustrates a cross sectional viewtaken along the line 1E-1E in FIG. 1D. FIG. 1F illustrates a magnifiedview of the left most turn 112 of the helical profile. As shown, thecatheter 100 can include an inflation lumen 150, a guide wire lumen 152,and a pull wire 154 or pull wire lumen 154. A variation of the deviceincludes an inflation lumen 150 that is bounded by an expandablematerial 156 and a flexible material 158. The flexible material allowsfor selective flexing of the deformable section 104 while the expandablematerial 156 expands upon pressurization of the inflation lumen 150. Incertain variations, the elastic material 156 is oriented such that thematerial 156 expands outwardly from the helical shape while maintainingthe passage 120 so that flow remains through the organ or body lumen.

The elastic material can comprise a material commonly used in medicalelastic balloon. Examples of materials for the support/elastic materialcan include pebax or a mix of pebax and siloxane. The elastic materialcan be co-extruded with the flexible material. Also, variations of thedevice can include a proximal portion that comprises a stiffer materialthan the flexible material used in the deflectable section.

Furthermore, in certain variations, the device can automatically coilwithout the need for a separate pull wire given a specific selection ofmaterials. For example, in such a variation the elastic expandableballoon material is co-extruded or otherwise bonded to a non-elasticmaterial of the catheter and the two materials will have a differentstiffness and elongation stress strain curves. In such a variation, uponinflation of the elastic portion of the tube, since the length changeson only one wall of the tubing, the other wall is constrainted by theless elastic material. This results in the balloon segment of thecatheter automatically forming a helical coiled configuration uponexpansion. The diameter of the balloon and the diameter of the inflatedhelical balloon configuration can be pre-determined by selecting theappropriate design parameters, including material selection, durometers,length, and extrusion cross sectional profiles.

FIG. 1G illustrates expansion along the deformable section 104 byexpanding the elastic material 156 in a direction away from the helicalshape. As shown, the flexible material 158 allows for formation of thehelical shape but prevents occlusion of the passage 120.

FIG. 1H shows a cross sectional view taken along the line 1H-1H in FIG.1G. As shown, the elastic material 156 expands away from the helixbecause the inflation lumen is pressurized (either via a fluid or agas). FIG. 1H also illustrates the elastic material 158 as allowing fordeformation of the deflectable section 104 but also providing a supportfor the flexible material 156 to expand.

FIG. 2A illustrates a cross section of the deformable section 104 asshown in FIG. 1F. Again, the inflation lumen 150 is bounded by anexpandable material 156 and the flexible material 158. The flexiblematerial allows for selective flexing of the deformable section 104while the expandable material 156 expands upon pressurization of theinflation lumen 150. Again, the elastic material 156 can be orientedsuch that the material 156 expands outwardly from the helical shapewhile maintaining the passage 120 so that flow remains through the organor body lumen.

In one example, the non-expandable portion of the device can befabricated from Peba, Polyurethane , Nylon or a blend of Polyurethaneand Siloxane, or Peba and Siloxane, or Nylon and Siloxane. In thevariations comprising Peba and Siloxane, or Polyurethan and Siloxane, orNylon and Siloxane, the extrusion is processed such that Siloxane isuniformaly dispersed through theother material. By having uniformdisbursement of the Siloxane allows for uniform increased lubricitythroughout the extrusion. Alternate variations include a devicefabricated from any commonly known material used in medical deviceapplications.

FIG. 2B shows a partial view of a deformable section 104 to illustratethe rotation of the cross section of the deformable section 104. As oneexample, FIG. 2B shows the deformable section 104 when it is in thegenerally linear configuration shown in FIG. 1A. FIG. 2B shows a numberof cross sectional views taken along the lines 2C/2C through 2K/2K. Asshown, the cross section rotates along a length of the deflectablesection 104 such that the different materials forming the cross sectionhelically rotate along the deflected portion 104. The rate of rotationand/or the length over which the cross section rotates can beselectively chosen to produce characteristics required for theparticular application.

FIGS. 3A to 3C illustrate variations of the helical shape 110 of variousdeflectable sections 104. FIG. 3A illustrates a helical shape having auniform diameter 170, 172 between the turns of the helix as well as auniform pitch 174. FIG. 3B illustrates a varying diameter. In thisexample, the diameter 174 decreases in a distal direction such that thedistal turn has a smaller diameter 176 than the proximal turn. FIG. 3Cillustrates a helical shape having varying pitch as measured bydistances 178, 180, 182. As shown, the pitch expands in a distaldirection. However, the pitch can expand in a proximal direction aswell.

FIG. 4A illustrates a variation of a catheter 100 having a singlehelical turn 112. FIG. 4B illustrates a side view of the catheter 100 ofFIG. 4A. FIG. 4C shows the variation of FIG. 4A upon expansion of theelastic material 156 while the flexible material 158 deforms to form theturn 112 and provide support to form the passage 120. FIG. 4C also showsa guidewire 188 being advanced through a guidewire lumen.

FIGS. 5A to 5C illustrate one example of a method of using a catheter100 as described herein. As shown in FIG. 5A, a catheter 100 is advancedthrough a vessel 10 or organ (in this variation the vessel comprises anaortic arch). However, the catheter 100 can be sized to fit variousorgans or vessels in the body. The catheter 100 can optionally be usedto expand an implant 200 within the vessel 10. Alternatively, thecatheter 100 can be used alone to provide an expansion force against theorgan or vessel. FIG. 5B illustrates transformation of the deflectablesection 104 of the catheter 100 into a helix. As shown, this canoptionally partially expand the implant 202 for positioning or partialdeployment. FIG. 5C shows expansion of the elastic material to fullydeploy the implant 202. As described above, flow continues in the vessel10 due to the passage in the helical shape.

FIG. 6A shows a variation of a device having a guide wire lumen 152 thatextends through the device and has multiple openings 114 to allow aguidewire to pass outside of the deflectable section 104 and thenreenter the device 100 at an opening 114 in the distal portion 102 sothat the guidewire can pass through a distal guidewire opening 114. Asshown, the guidewire lumen 152 can extend adjacent to a pull wire 108 orother similar means in the proximal portion 106 of the device 100.However, at or near the deflectable section 104, the guidewire lumenexits the device 100 at opening 114 so that the guidewire can exit thedevice along the deflectable section 104 and then reenter the device ata second opening 114 adjacent to the distal portion 102 of the device.This configuration allows the guidewire to extend out of the distal mostopening 114.

FIG. 6B illustrates a guidewire 188 extending through the device 100 butpassing through the helical turns 110. The guidewire 188 then re-entersthe distal portion 102 of the device 100 so that a physician cannavigate the distal portion 102 of the device 100 using the guidewire188.

FIGS.7A and 7B show another variation of a device 100 having an actuator194 that allows for expansion of the deflectable section 104 as it formsthe helical turns 112. FIG. 7A shows the device 100 in a linearconfiguration where a pull wire 108 that extends through the deflectablesection 104 also extends proximally and is coupled to the actuator 192.In this variation, the pull wire 108 is coupled to a piston 194 in theactuator 192. The actuator 129 is also coupled to a valve 190 (in thisvariation the valve is a three way valve. The valve is also coupled to afitting 186 of the device 100. It is noted that the pull wire 108 can beseparate from the guide wire that is inserted through the guide wirelumen 152.

FIG. 7B represents a fluid source being driven through the valve 190 asrepresented by arrow 210. The fluid 210 travels through the device 100as shown by arrow 212 to expand the expandable area as discussed above.However, the three way valve 190 also causes fluid to pressurize theactuator 192 to drive the piston 194 out of the actuator 192. Since thepiston 194 is coupled to the pull wire 108, movement of the piston 194causes proximal movement of the pull wire as noted by arrow 216. Themovement of the pull wire causes the turns 112 of the deflectablesection 104 to form the helical shape.

FIGS. 8A-8D illustrate another aspect for use with the devices describedherein. The figures show a cross sectional view of an expandable sectionof the device 100. In this variation, the device 100 includes a fluiddelivery lumen 162 that permits delivery of a fluid substance from themain body of the catheter. FIG. 8A shows a variation in which a fluiddelivery lumen 162 is located in an expandable wall 156 of the device100. Alternate variations allow for the fluid delivery lumen 162 to bepositioned anywhere within the walls of the device 100. FIG. 8Billustrates a variation of the device 100 with a plurality of fluiddelivery lumens 162. Although not depicted in FIGS. 8A-8D, the fluiddelivery lumen 162 will have one or more ports that deposit the fluid ata desired location outside the device body 100. FIG. 8C show the device100 in an expanded state where the fluid delivery lumen 162 assumes theshape of an oval without being occluded. FIG. 8D illustrates anothervariation of a device 100 where the fluid delivery lumen 162 is formedby an expandable section 163 on an exterior of the catheter 100. Thisconfiguration allows for a large fluid delivery lumen that can expand tofacilitate passage of a fluid. The fluid delivery lumen 162 will haveone or more fluid delivery ports (not shown in FIGS. 8A to 8D) thatpermit delivery of the fluid when the catheter is in the straight and/orcoiled shape.

FIG. 9A and 9B illustrate variations of a device as described hereinwhere one or more fluid ports 128 terminate on an exterior surface ofthe coiled or helical portion of the device 100. The ports 128, whichare in fluid communication with the fluid lumen, can be positioned oneither side or both sides of the helical turn 112 of the deflectablesection 104. In such a configuration, placing the ports 128 on the sidesand/or inside of the helical turn 112 prevents the port 128 from beingblocked during expansion of the deflectable section 104. FIG. 9Billustrates another variation of a device 100 having ports 128. In thisvariation, the ports 128 are positioned centrally on the turns 128 ofthe deflectable section 104. FIGS. 9A and 9B also show the device 100having any number of hubs 196, 198 that can be fluidly coupled to thefluid delivery lumen (not shown) such that an external source of fluidcan be coupled to the respective hub allowing for delivery of the fluid.In additional variations, the ports can be located on additionalportions of the catheter, including but not limited to, thenon-expanding portion of the catheter.

FIG. 10 illustrates a variation of the device 100 described hereinpositioned into a coronary artery 14 on a heart 12 where the deflectablesection 104 is coiled while allowing blood flow through the coronaryvessel 14. The device 100 also permits delivery of drugs, medicine orother agents through the ports described above.

FIGS. 11A and 11B show additional variations of the device where thehelical or deflectable section is joined to a proximal portion 106 and adistal portion 102 such that the deflectable section comprises anelastic material 156 and a flexible material 158 to allow deformationinto a helical shape. As shown, the deflectable section 104 canoptionally selected to be a clear or semi-clear material.

FIGS. 12A to 12D show another example of a device 100 having a featurethat aids in the formation of the deflectable section 104 into a helicalstructure. As with the other variations described herein, the featuresand aspects of each example discussed herein can be combined with otherdisclosed variations of the device where such features do not conflict.

As shown in FIG. 12A, the device 100 includes a wire 204 (which can be awire, suture, thread, strand or similar structure) that extends from aproximal end of the device 100 (e.g., through a hub 196 as shown) to afirst opening 208 that is located proximally to (or on a proximal end)of the deflectable section 104. The wire 204 extends outside of thedevice along a portion of the deflectable section 104 and re-enters thedevice 100 a location 218 distal to (or at a distal end of) thedeflectable section 104. The wire 204 can be fixed at the distallocation 218 or can be free floating as long as it can remain within thedevice a the distal opening 218. FIG. 12A also illustrates thisvariation of the device 100 as having a hub 196 with a locking feature206. The locking feature 206 secures the wire 204 when desired. Asdiscussed below, once the deflectable section is positioned as desired,the wire 204 can be locked into place using the locking feature 206 tosecure the helical shape of the deflectable section. In an additionalvariation, the wire 204 can be coupled to a piston mechanism asdescribed in FIGS. 7A and 7B above.

FIG. 12B illustrates the deflectable section 104 as it starts to coil.As mentioned above, the deflectable section 104 can being to assume acoil shape using a pull wire or the natural characteristics of thematerials forming the device 100. As shown, the wire 204 remainsexterior to the device 100. FIG. 12C illustrates the wire 204 beingdrawn to close the distance between the proximal opening 208 and thedistal opening 218. This action permits the deflectable section 104 ofthe device 100 to form a coiled shape as desired. FIG. 12D illustratesthe helical shape of the deformable section 104 when the wire (notshown) secures the helical coil of the device. Although the variationdepicted in FIGS. 12A to 12D only coils a single turn of the helicalshape, any number of wires can be used to form additional turns of thedevice. Alternatively, a wire can pass through any number of turns ofthe deflectable section 104.

In another variation, the device can include a string or other similarmember that is attached at a proximal end of the distal tip and extendsthrough the pullwire lumen exiting just where the first balloon loopstarts. Then when the catheter forms its fist loop, the string goes backinto the lumen. This could be repeated depending on the number of loopsof the balloon. When the catheter is straight before inflation, thestring is external for a few inches at either one spot along the lengthof catheter at the loop section, or two spots if it had two loops. Thestring can be pulled from the back either manually or with the syringeplunger concept that di disclosed above.

1. (canceled)
 2. (canceled)
 3. A catheter comprising: a deflectablesection, where the deflectable section comprises an elastic material, aflexible support material, and an inflation lumen bounded by both theelastic material and the flexible support material, where thedeflectable section is deflectable from a non-deflected configuration toa deflected configuration, where when the deflectable section is in thedeflected configuration, the elastic material, the inflation lumen, andthe flexible support material extend helically around a passage, andwhere the elastic material is farther from the flexible support materialwhen the deflectable section is in the deflected configuration than whenthe deflectable section is in the non-deflected configuration.
 4. Thecatheter of claim 3, where when the deflectable section is in thenon-deflected configuration, the elastic material and the flexiblesupport material extend helically around the inflation lumen.
 5. Thecatheter of claim 3, where when the deflectable section is in thenon-deflected configuration, the inflation lumen has a non-helicalshape.
 6. The catheter of claim 3, where when the deflectable section isin the non-deflected configuration, the inflation lumen has a generallylinear configuration.
 7. The catheter of claim 3, where the inflationlumen is more curved when the deflectable section is in the deflectedconfiguration than when the deflectable section is in the non-deflectedconfiguration.
 8. The catheter of claim 3, where when the deflectablesection is in the non-deflected configuration, the elastic material andthe flexible support material extend helically around the inflationlumen along a first helix having a first pitch, where when thedeflectable section is in the deflected configuration, the elasticmaterial and the flexible support material extend helically around thepassage along a second helix having a second pitch, and where the secondpitch is less than the first pitch.
 9. The catheter of claim 3, wherethe passage has a passage cross-sectional size and the inflation lumenhas an inflation lumen cross-sectional size, and where the passagecross-sectional size is greater than the inflation lumen cross-sectionalsize.
 10. The catheter of claim 3, where the passage is bounded by theflexible support material.
 11. The catheter of claim 3, where thedeflectable section is deflectable with a pull wire.
 12. A cathetercomprising: a deflectable section, where the deflectable sectioncomprises an elastic material, a flexible support material, and aninflation lumen bounded by both the elastic material and the flexiblesupport material, where the deflectable section is deflectable from afirst configuration to a second configuration, where when thedeflectable section is in the first configuration, the elastic materialand the flexible support material extend helically around the inflationlumen, and where when a pressure within the inflation lumen increases,the elastic material expands away from the flexible support material.13. The catheter of claim 12, where when the deflectable section is inthe second configuration, the elastic material, the inflation lumen, andthe flexible support material extend helically around a passage.
 14. Thecatheter of claim 12, where when the deflectable section is in the firstconfiguration, the inflation lumen has a non-helical shape, and wherewhen the deflectable section is in the second configuration, theinflation lumen has a helical shape.
 15. The catheter of claim 12, wherewhen the deflectable section is in the first configuration, theinflation lumen has a generally linear configuration.
 16. The catheterof claim 12, where the inflation lumen is more curved when thedeflectable section is in the second configuration than when thedeflectable section is in the first configuration.
 17. The catheter ofclaim 12, where when the deflectable section is in the firstconfiguration, the elastic material and the flexible support materialextend helically around the inflation lumen along a first helix having afirst pitch, where when the deflectable section is in the secondconfiguration, the elastic material and the flexible support materialextend helically around a passage along a second helix having a secondpitch, and where the second pitch is less than the first pitch.
 18. Thecatheter of claim 12, where the deflectable section is deflectable witha pull wire.
 19. A catheter comprising: a deflectable section having adeflectable cross section; where the deflectable section cross sectioncomprises a first material, a second material, and an inflation lumenbounded by both the first material and the second material, where thefirst material has different material properties than the secondmaterial, where the deflectable section is deflectable from anon-deflected configuration to a deflected configuration, where when thedeflectable section is in the non-deflected configuration, thedeflectable section cross section rotates along a length of thedeflectable section such that the first material and the second materialextend helically along the length of the deflectable section, where whenthe deflectable section is in the deflected configuration, thedeflectable section has a helical or coiled profile; where when thedeflectable section is in the non-deflected configuration, a firstpressure is in the inflation lumen, where when the deflectable sectionis in the deflected configuration, a second pressure is in the inflationlumen, where the second pressure is greater than the first pressure, andwhere the first material is farther from the inflation lumen when thedeflectable section is in the deflected configuration than when thedeflectable section is in the non-deflected configuration.
 20. Thecatheter of claim 19, where when the deflectable section is in thehelical or coiled profile, the flexible support material is locatedalong an internal diameter of the helical or coiled profile and theelastic material is located on an external diameter of the helical orcoiled profile.
 21. The catheter of claim 19, where when the deflectablesection is in the helical or coiled profile, the elastic material andthe flexible support material extend helically around a passage.
 22. Thecatheter of claim 19, where the material properties comprise at leastone of hardness, flexibility, and elasticity, or where the deflectablesection is deflectable with a pull wire.